BEUDAMED
    FDA Adverse Event Death Summary report: N

    MCGRATH

    MDR report key: 9179250 · Received October 11, 2019

    Report

    Report Number
    3010244187-2019-00015
    Event Type
    Death
    Date Received
    October 11, 2019
    Date of Event
    January 24, 2017
    Report Date
    October 11, 2019
    Manufacturer
    AIRCRAFT MEDICAL LIMITED
    Product Code
    CCW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: VIDEO LARYNGOSCOPY VS DIRECT LARYNGOSCOPY ON SUCCESSFUL FIRST-PASS OROTRACHEAL INTUBATION AMONG ICU PATIENTS SOURCE: JEAN BAPTISTE LASCARROU, MD, 2017, JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PLI 20: ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED BETWEEN MAY 2015 AND JANUARY 2016, THE DEVICE WAS USED TO DETERMINE IF ROUTINE USE FOR OROTRACHEAL INTUBATION OF PATIENTS IN THE ICU INCREASED THE FREQUENCY OF SUCCESSFUL FIRST-PASS INTUBATION COMPARED WITH USE OF THE (B)(6) DIRECT LARYNGOSCOPE. OUT OF 186 PATIENTS IN THE GROUP, THERE WAS ONE PATIENT DEATH. ALL BUT 2 PATIENTS WERE INTUBATED. IT WAS UNCLEAR WHETHER ALL COMPLICATIONS WERE DIRECTLY RELATED TO THE DEVICE OR DUE TO PATIENT STATUS AT THE TIME OF INTUBATION/OTHER COMORBIDITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    976070 MCGRATH LARYNGOSCOPE, RIGID CCW AIRCRAFT MEDICAL LIMITED 300-000-000

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L| R